TerminatedNot Applicable

Fluoroquinolone Resistance Prevalence Study

Stopped: Discontinued Recruitment

United States105 participantsStarted 2022-07-08

Plain-language summary

This is an exploratory study to determine the prevalence of fluoroquinolone resistance in patients receiving dose-intense melphalan with autologous peripheral blood stem cell (PBSC) transplantation in the treatment of multiple myeloma (MM). These data may be used in subsequent studies exploring the use of prophylaxis in this patient population.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects \>18 yrs of age. * Diagnosis of multiple myeloma undergoing (first or subsequent) autologous PBSC transplantation. * Transplant conditioning with melphalan 200 mg/m2. * PBSC cell dose of \>2x10e6 CD34+ cells/kg. * Able to receive fluoroquinolone prophylaxis. * Subjects must give consent for enrollment into this study. Exclusion Criteria: * Unwillingness to provide informed consent. * Enrollment into a treatment protocol prescribing antibiotic prophylaxis. * A diagnosis other than multiple myeloma. * Receiving a conditioning regimen other than melphalan 200 mg/m2. * Known light-chain amyloid deposition in any organ.

What they're measuring

Prevalence of FRE

Timeframe: Duration between Apheresis Consultation and Day +100

Trial details

NCT IDNCT05824689

SponsorHackensack Meridian Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-17

View on ClinicalTrials.gov More Multiple Myeloma trials